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Non-alcoholic Fatty Liver DiseasePhase 2NCT04048876

Study to Evaluate the Efficacy and Safety of CC-90001 in Participants With Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis

A Phase 2 study testing CC-90001 in people with Non-alcoholic Fatty Liver Disease and Liver Cirrhosis, run by Celgene at 142 sites in 10 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, multinational, dose-finding study evaluating the efficacy of three treatment doses of CC-90001 compared with placebo, in Non-alcoholic Steatohepatitis (NASH) participants with Stage 2, Stage 3 liver fibrosis. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CC-90001
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
56 participants
Where
142 sitesin 10 countries
Study dates
14 Aug 2019to 28 Sep 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Key Inclusion Criteria Diagnosis of non-alcoholic steatohepatitis (NASH) with presence of Stage 2, Stage 3 fibrosis based of the non-alcoholic steatohepatitis (NASH) Clinical Research Network (CRN) Histologic Scoring System and a nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS) of 4 or higher

Who cannot join

  • Key Exclusion Criteria
  • History or evidence of decompensated liver disease,
  • Hepatitis and fibrosis more likely related to etiologies other than non-alcoholic steatohepatitis (NASH).
  • Participant has urine ethyl glucuronide (EtG) > 500 ng/mL at Screening.
  • History or positive screen for human immunodeficiency virus (HIV) infection or congenital or human immunodeficiency virus (HIV)-unrelated acquired immunodeficiencies (eg, common variable immunodeficiency [CVID]).
  • History of hepatitis B and/or hepatitis C.
  • History of malignancy within the last 5 years (exceptions: excised and cured basal/squamous cell skin carcinomas and cervical carcinoma in situ).
  • Pregnancy or lactation.

Trial locations and contacts

142 sites in 10 countries.

142 sites in 10 countries

United States64 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Texas Clinical Research Institute LLC

    Arlington, Texas, 76012

  • University of Colorado, School of Medicine - Hepatology Clinic - Anschutz

    Aurora, Colorado, 80045

  • The Institute for Digestive Health & Liver Disease at Mercy Medical Center

    Baltimore, Maryland, 21202

  • Boston University Medical Center

    Boston, Massachusetts, 02118

  • Beth Israel Deaconness Medical Center

    Boston, Massachusetts, 02215

  • Bridgeport Hospital

    Bridgeport, Connecticut, 06610

  • University of Vermont Medical Center Gastro

    Burlington, Vermont, 05401

  • Digestive Disease Associates, PA

    Catonsville, Maryland, 21228

  • Local Institution - 102

    Chapel Hill, North Carolina, 27514

  • UNC Hospitals GI Medicine Clinic

    Chapel Hill, North Carolina, 27514

  • ClinSearch LLC

    Chattanooga, Tennessee, 37421

  • Rush University Medical Center - University Cardiovascular Surgeons

    Chicago, Illinois, 60612

  • University of Chicago Medicine

    Chicago, Illinois, 60637

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80907

  • Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

  • Liver Institute at Methodist Dallas

    Dallas, Texas, 75203

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Duke University School of Medicine

    Durham, North Carolina, 27710

  • South Denver Gastroenterology

    Englewood, Colorado, 80113

  • Brooke Army Medical Center Francis Street Medical Center

    Fort Sam Houston, Texas, 78235-8200

  • Gastro One

    Germantown, Tennessee, 38138

  • Baylor College of Medicine - Baylor Heart Clinic

    Houston, Texas, 77030

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • Carolinas HealthCare System Digestive Health

    Huntersville, North Carolina, 28078

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • UC San Diego School of Medicine

    La Jolla, California, 92093-0960

  • Florida Digestive Health Specialists

    Lakewood Rch, Florida, 34202-2719

  • Local Institution - 176

    Lakewood Rch, Florida, 34202-2719

  • Cedars-Sinai Comprehensive Transplant Center

    Los Angeles, California, 90048

  • Gastrointestinal Specialists of Georgia, PC

    Marietta, Georgia, 30060

  • University of Miami Schiff Center for Liver Diseases

    Miami, Florida, 33136

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Yale Cancer Center

    New Haven, Connecticut, 06520

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • Beth Israel Medical Center

    New York, New York, 10003

  • Concorde Medical Group

    New York, New York, 10016

  • New York Presbyterian Hospital - Weill-Cornell

    New York, New York, 10021

  • Bon Secours Liver Institute of Hampton Roads

    Newport News, Virginia, 23603

  • Digestive and Liver Disease Specialists

    Norfolk, Virginia, 23502

  • University of Nebraska

    Omaha, Nebraska, 68198-7680

  • IMIC, Inc.

    Palmetto Bay, Florida, 33157

  • California Liver Research Institute

    Pasadena, California, 91105

  • Saint Joseph's Hosptial and Medical Center - Barrow Neurological Institute

    Phoenix, Arizona, 85013

  • Mayo Clinic Phoenix

    Phoenix, Arizona, 85054

  • University of Pittsburgh Medical Center - Center for Liver Diseases

    Pittsburgh, Pennsylvania, 15213

  • Advanced Medical Research Center

    Port Orange, Florida, 32127

  • University Gastroenterology

    Providence, Rhode Island, 02905

  • Inland Empire Liver Foundation

    Rialto, California, 92377

  • Bon Secours Liver Institute of Richmond

    Richmond, Virginia, 23226

  • McGuire Veterans Affairs Medical Center

    Richmond, Virginia, 23249

  • Virginia Commonwealth University School of Medicine

    Richmond, Virginia, 23298-0341

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Digestive Health Associates of Texas (DHAT)

    Rockwell, Texas, 75032

  • University of California Davis Medical Center

    Sacramento, California, 95817

  • American Research Corporation

    San Antonio, Texas, 78215

  • Southern California GI & Liver Centers

    San Clemente, California, 92673

  • University of Washington Harborview Medical Center

    Seattle, Washington, 98104

  • Liver Institute Northwest PLLC

    Seattle, Washington, 98105

  • WestGlen Gastrointestinal Consultants, P.A.

    Shawnee Mission, Kansas, 66217

  • Saint Louis University School of Medicine

    St Louis, Missouri, 63110-0250

  • Tampa General Hospital

    Tampa, Florida, 33606

Other trials in United States

Japan26 sites

  • Hamamatsu University Hospital

    Hamamatsu, 431-3192

  • Local Institution - 604

    Hamamatsu, 431-3192

  • Local Institution - 608

    Kashihara, 634-8522

  • Nara Medical University Hospital

    Kashihara, 634-8522

  • Local Institution - 601

    Kawasaki, 215-0026

  • Shin-Yurigaoka General Hospital

    Kawasaki, 215-0026

  • Kurume University Hospital

    Kurume, Fukuoka, 830-0011

  • Local Institution - 607

    Kurume, Fukuoka, 830-0011

  • Local Institution - 615

    Kyoto, 602-8566

  • University Hospital, Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

  • Japanese Red Cross Musashino Hospital

    Musashino, 180-8610

  • Local Institution - 602

    Musashino, 180-8610

  • Aichi Medical University Hospital

    Nagakute, 480-1195

  • Local Institution - 611

    Nagakute, 480-1195

  • Local Institution - 613

    Ōgaki, 503-8502

  • Ogaki Municipal Hospital

    Ōgaki, 503-8502

  • Local Institution - 603

    Osaka-Fu, 565-0871

  • Osaka University Hospital OUH

    Osaka-Fu, 565-0871

  • Local Institution - 609

    Saga, 849-8501

  • Saga University Hospital

    Saga, 849-8501

  • Belland General Hospital

    Sakaishi, 599-8247

  • Local Institution - 605

    Sakaishi, 599-8247

  • Local Institution - 612

    Suita, 564-0013

  • Saiseikai Suita Hospital

    Suita, 564-0013

  • Local Institution - 600

    Yokohama, Kanagawa, 213-8507

  • Yokohama City University Hospital

    Yokohama, Kanagawa, 213-8507

Other trials in Japan

United Kingdom10 sites

  • University of Birmingham Institute of Biomedical Research

    Birmingham, B15 2TT

  • Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital

    Cambridge, CB2 0QQ

  • Local Institution - 558

    Hardwick, TS19 8PE

  • North Tees (DRS) Synexus North Teesside Clinical Research Centre

    Hardwick, TS19 8PE

  • Local Institution - 556

    Hexham, NE46 1QJ

  • Synexus Hexham Clinical Research Centre, Hexham (DRS)

    Hexham, NE46 1QJ

  • Kings College Hospital

    London, SE5 9RS

  • Chelsea and Westminster Hospital NHS Foundation Trust - Chelsea and Westminster Hospital (CWH)

    London, SW10 9NH

  • Imperial College University Trust

    London, W2 1NY

  • Local Institution - 559

    London, W2 1NY

Other trials in United Kingdom

France9 sites

  • CHU d'Angers

    Angers, 49033

  • Assistance Publique - Hopitaux de Paris - Hopital Beaujon

    Clichy, 92110

  • Hopital de la Croix-Rousse

    Lyon, 69317

  • Assistance Publique - Hopitaux de Paris - Hopital Cochin

    Paris, 75014

  • Assistance Publique - Hopitaux de Paris - Hopital Universitaire Pitie Salpetriere

    Paris, 75651

  • Hopital Haut Leveque

    Pessac, 33604

  • Centre Hospitalier Universitaire de Rennes - Hopital de Pontchaillou

    Rennes, 35033

  • Hopital Hautepierre

    Strasbourg, 67098

  • Local Institution - 356

    Strasbourg, 67098

Other trials in France

Poland8 sites

  • Katowice (DRS)Synexus Polska Sp. z o.o. Oddzial w Katowicach

    Katowice, 40-040

  • Samodzielny Publiczny Centralny Szpital Kliniczny Im Prof. Kornela Gibinskiego

    Katowice, 40-752

  • Krakow Medical Center LLC

    Krakow, 31-501

  • Lodz (DRS)Synexus Polska Sp. Z o.o. Oddzial w Lodzi

    Lodz, 90-127

  • Wojewodzki Specjalistyczny Szpital im. dr Wladyslawa Bieganskiego

    Lodz, 91-347

  • ID Clinic

    Mysłowice, 41-400

  • Local Institution - 453

    Mysłowice, 41-400

  • Synexus SCM Sp. z o.o. Oddz. Warszawa

    Warsaw, 01-192

Other trials in Poland

South Korea7 sites

  • Soon Chun Hyang University Hospital Bucheon

    Bucheon-si, 420-853

  • Hanyang University Seoul Hospital

    Seoul, 04763

  • Korea University Hospital at Guro

    Seoul, 152-703

  • Boramae Medical Center

    Seoul, 156-707

  • Seoul National University Hospital

    Seoul, 3080

  • Asan Medical Center

    Seoul, 5505

  • Yonsei University Wonju Severance Christian Hospital

    Wŏnju, 26426

Other trials in South Korea

Australia5 sites

  • University of Sydney - Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • Nepean Hospital

    Kingswood, New South Wales, 2751

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Mater Hospital Brisbane

    South Brisbane, Queensland, 4101

Other trials in Australia

Spain5 sites

  • Hospital Val d'Hebron

    Barcelona, 08035

  • University Hospital of Girona Dr. Josep Trueta

    Girona, 17007

  • Parc Tauli Hospital Universitari

    Sabadell (Barcelona), 08208

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Virgen del Rocio

    Seville, 41013

Other trials in Spain

Canada4 sites

  • University of Calgary, Cumming School of Medicine

    Calgary, Alberta, T2N 4Z6

  • South Edmonton Gastroenterology

    Edmonton, Alberta, T6L 6K3

  • Toronto Center for Liver Disease - Francis Family Liver Clinic

    Toronto, Ontario, M5G 2C4

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Germany4 sites

  • Universitaetsklinikum der RWTH Aachen

    Aachen, 52074

  • Johann Wolfgang Goethe University Hospital

    Frankfurt am Main, 60590

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

    Mainz, 55131

  • Universitaetsklinikum Muenster

    Münster, 48149

Other trials in Germany

About this study

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Finding Study To Evaluate The Efficacy and Safety Of CC-90001 In Subjects With Non-Alcoholic Steatohepatitis (NASH) and Liver Fibrosis

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, multinational, dose-finding study evaluating the efficacy of three treatment doses of CC-90001 compared with placebo, in Non-alcoholic Steatohepatitis (NASH) participants with Stage 2, Stage 3 liver fibrosis.

This study is designed to assess response to treatment on measures of fibrosis and other efficacy parameters. It will also assess dose response and overall safety.

Being tested
CC-90001, Placebo
Keywords
Non-Alcoholic Steatohepatitis, NASH, Non-Alcoholic Fatty Liver, Liver Fibrosis, CC-90001
Medical subject headings
Non-alcoholic Fatty Liver Disease, Liver Cirrhosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CC-90001Drug

    oral

  • PlaceboDrug

    oral

Study groups in NCT04048876
Study groupRoleWhat they receive
CC-90001 400 mg once daily (QD)ExperimentalCC-90001 400 mg QD
Receives: Drug: CC-90001
CC-90001 200 mg once dailyExperimentalCC-90001 200 mg QD
Receives: Drug: CC-90001
CC-90001 100 mg once dailyExperimentalCC-90001 100 mg QD
Receives: Drug: CC-90001
Placebo once dailyPlacebo comparatorPlacebo QD
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Who Achieve a ≥1 Stage Improvement in Liver Fibrosis Using the NASH CRN Histological Scoring System at Week 52

    Percentage of participants who achieve a ≥1 stage improvement in liver fibrosis using the NASH CRN Histological Scoring System at Week 52. A participant with a change of ≤ -1 from baseline in fibrosis stage is considered as an improvement responder for this endpoint.

    The NASH CRN Histologic Scoring System comprised:

    steatosis (0 to 3) lobular inflammation (0 to 3) hepatocellular ballooning (0 to 2) fibrosis disease stage (0 to 4)

    • Stage 0 - None;
    • Stage 1a - Mild (delicate) zone 3 perisinusoidal fibrosis;
    • Stage 1b - Moderate (dense) zone 3 perisinusoidal fibrosis;
    • Stage 1c - Portal/periportal fibrosis only;
    • Stage 2 - Zone 3 perisinusoidal fibrosis with portal/periportal fibrosis;
    • Stage 3 - Bridging fibrosis;
    • Stage 4 - Cirrhosis.

    Measured: From baseline up to week 52

Secondary outcomes (18)

  1. Percentage of Participants With no Worsening of Steatohepatitis and ≥1 Stage Improvement in Liver Fibrosis Score at Week 52

    Percentage of participants with no worsening of steatohepatitis and ≥1 stage improvement in liver fibrosis score at week 52 using the NASH CRN Histological Scoring System at Week 52. A participant with a change of ≥ -1 from baseline in fibrosis stage and no worsening in steatohepatitis is considered as an improvement responder for this endpoint.

    The NASH CRN Histologic Scoring System comprised:

    steatosis (0 to 3) lobular inflammation (0 to 3) hepatocellular ballooning (0 to 2) fibrosis disease stage (0 to 4)

    • Stage 0 - None;
    • Stage 1a - Mild (delicate) zone 3 perisinusoidal fibrosis;
    • Stage 1b - Moderate (dense) zone 3 perisinusoidal fibrosis;
    • Stage 1c - Portal/periportal fibrosis only;
    • Stage 2 - Zone 3 perisinusoidal fibrosis with portal/periportal fibrosis;
    • Stage 3 - Bridging fibrosis;
    • Stage 4 - Cirrhosis.

    Measured: From baseline up to week 52

  2. Percentage of Participants With Improvement in Total NAS

    Percentage of participants with an improvement of ≥ 2 points in the total NAS with improvement in more than one category of steatosis, lobular inflammation, and hepatocellular ballooning, and no worsening of liver fibrosis at Week 52. A participant with a change of ≤ -2 from baseline in total NAS, a change of ≤ -1 from baseline in more than one subscore, and a change of ≤ 0 from baseline in fibrosis stage is considered as a responder for this endpoint.

    Measured: From baseline up to week 52

  3. Percentage of Participants With Resolution of NASH

    Percentage of participants who demonstrate absence of ballooning, and lobular inflammation score of 0 or 1 at Week 52.

    Absence of ballooning is defined as a score of 0 in hepatocellular ballooning. A participant with a score of 0 in ballooning, a score of 0 or 1 in lobular inflammation is considered as a responder for this endpoint.

    Measured: From baseline up to week 52

  4. Percentage of Participants With Resolution of NASH With no Worsening of Liver Fibrosis

    Percentage of participants who demonstrate absence of ballooning, and lobular inflammation score of 0 or 1 and no worsening of liver fibrosis at Week 52

    Absence of ballooning is defined as a score of 0 in hepatocellular ballooning. Worsening of fibrosis stage was defined as progression of NASH CRN fibrosis stage. A participant with a score of 0 in ballooning, a score of 0 or 1 in lobular inflammation, and a change of ≤ 0 from baseline in fibrosis stage is considered as a responder for this endpoint.

    Measured: From baseline up to week 52

  5. Percentage of Participants Who Progressed to Cirrhosis

    Percentage of participants who progressed to cirrhosis

    Measured: From baseline up to week 52

  6. Mean Change From Baseline in Liver Biochemistry

    Mean change from Baseline in serum aspartate aminotransferase (AST), alanine aminotransferase (ALT) and γ-glutamyl transferase (GGT)

    Measured: From baseline up to week 52

  7. Mean Change From Baseline in Metabolic Parameters

    Mean change from baseline in total low density cholesterol (LDL) high density cholesterol (HDL), and triglycerides

    Measured: From baseline up to week 52

  8. Cmax

    Cmax is defined as maximum plasma concentration of the drug

    Measured: Day 1 and at Week 4

  9. Tmax

    Tmax is defined is the time to maximum plasma concentration

    Measured: Day 1 and at Week 4

  10. AUC (0-t)

    Area under the plasma concentration time-curve. AUC from time 0 to the last time of quantifiable concentration

    Measured: Day 1 and at Week 4

  11. AUC t

    Area under the plasma concentration time-curve. AUC over the dosing interval.

    Measured: Day 1 and at Week 4

  12. Apparent Total Body Clearance of the Drug

    Apparent total body clearance of the drug (CL/F)

    Measured: At Week 4

  13. Number of Participants With Treatment Related Safety Events

    Number of participants with treatment related safety events

    Measured: From baseline up to week 52

  14. Mean Change From Baseline of ECG Results - PR Intervals

    Mean change from baseline in PR interval

    PR Interval: Atrial depolarization and conduction through the AV node Normal Range: 0.12 - 0.20 (120 to 200 msec)

    Measured: From baseline up to week 52

  15. Mean Change From Baseline of ECG Results - QRS Duration

    Mean change from baseline in QRS duration QRS Duration: Ventricular depolarization and atrial repolarization Normal Range: 0.08 to 0.10 (80 to 100 msec)

    Measured: From baseline up to week 52

  16. Mean Change From Baseline of ECG Results - QT Interval

    Mean change from baseline in QT interval

    QT Interval: Ventricular depolarization plus ventricular repolarization Normal Range: 400 to 460 msec

    Measured: From baseline up to week 52

  17. Mean Change From Baseline of ECG Results - QTcB Interval

    Mean change from baseline in QTcB interval

    QT Interval: Ventricular depolarization plus ventricular repolarization Normal Range: 400 to 460 msec

    QTc: QT interval corrected based on the patient's heart rate

    QTcB: An electrocardiographic finding in which the QT interval corrected for heart rate using Bazzett's formula. QTc = QT/√(RR) RR= Respiration Rate

    Measured: From baseline up to week 52

  18. Mean Change From Baseline of ECG Results - QTcF Interval

    Mean change from baseline in QTcF interval

    QT Interval: Ventricular depolarization plus ventricular repolarization Normal Range: 400 to 460 msec

    QTc: QT interval corrected based on the patient's heart rate

    QTcF: An electrocardiographic finding in which the QT interval corrected for heart rate using Fridericia's formula. QTc = QT/∛(RR) RR = Respiration rate

    Measured: From baseline up to week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2019
  2. Study start14 Aug 2019
  3. Primary completion28 Sep 2021
  4. Study completion28 Sep 2021

Why it stopped: Business objectives have changed

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04048876
Sponsor's protocol ID
CC-90001-NASH-001
Other IDs
U1111-1235-3234, 2018-004431-79, 2018
Status last verified
Jun 2023
First submitted
17 Jul 2019
Last updated
7 Jun 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CC-90001 in people with Non-alcoholic Fatty Liver Disease and Liver Cirrhosis, run by Celgene at 142 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 142 sites in United States, Japan, United Kingdom, France, Poland and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Achieve a ≥1 Stage Improvement in Liver Fibrosis Using the NASH CRN Histological Scoring System at Week 52 (time frame: From baseline up to week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04048876.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.

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